Impact of Statins on Cytokine Expression in Pneumonia

This study has suspended participant recruitment.
Sponsor:
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00946166
First received: July 22, 2009
Last updated: August 3, 2011
Last verified: August 2011

July 22, 2009
August 3, 2011
July 2009
December 2014   (final data collection date for primary outcome measure)
Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels [ Time Frame: enrollment, 24h, 48h, 72h, hospital discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00946166 on ClinicalTrials.gov Archive Site
30-day mortality [ Time Frame: 30-days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Statins on Cytokine Expression in Pneumonia
Impact of Statins on Cytokine Expression in Pneumonia

The investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have pneumonia. The people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. Some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. The study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Community Acquired Pneumonia
  • Cardiovascular Risk Factors
  • Drug: simvastatin
    40 mg daily in the evening for a maximum of 14 days
  • Drug: Placebo
    Simvastatin-like placebo administered daily in the evening for a maximum of 14 days
  • Placebo Comparator: Placebo Control
    Subjects receive standard treatment for pneumonia and a simvastatin-like placebo
    Intervention: Drug: Placebo
  • Experimental: Simvastatin
    Subjects receive simvastatin in addition to standard pneumonia treatment
    Intervention: Drug: simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
24
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years of age,
  • Chart documentation by a clinician of an initial working diagnosis of pneumonia within 24 hours of admission,
  • Chest x-ray or other imaging evidence consistent with pneumonia within 48 hours of hospitalization, and
  • One of the following severity criteria: pneumonia severity index class III or higher, at least 2/5 components of the CURB-65, or ICU level care within 24 hours of admission.
  • Having one Food and Drug Agency approved indication for statin therapy

Exclusion Criteria:

  • Prior Treatment with one or more doses of a statin within 30-days prior to admission or during the current hospitalization.
  • Hospitalization > 24 hours at time of the diagnosis of pneumonia.
  • Hospitalization > 48 hours at time of study enrollment.
  • Residence in a skilled nursing facility.
  • Previously diagnosed human immunodeficiency virus infection with a current CD4 count < 200 cells/mm.
  • Immunosuppression
  • Patient or family decision to limit medical care ("comfort measures only").
  • Known allergy to statin therapy.
  • Active or planned pregnancy or breastfeeding.
  • Inability to take oral medications at the time of study enrollment.
  • Pre-existing liver disease or AST/ALT > 10% the upper limit of normal.
  • Creatinine phosphokinase (CPK or CK) > 50% above the upper limit of normal.
  • Partial ileal bypass.
  • Concurrent treatment with potential interacting drugs: ketoconazole, itraconazole, amiodarone, clarithromycin, erythromycin, cyclosporine, danazol, niacin, protease inhibitors, telithromycin, verapamil, gemfiborzil, ezetimibe (Zetia), nefazodone.
  • Transfer from an outside hospital.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00946166
HSC2009-183H
No
Eric M. Mortensen, MD, University of Texas Health Science Center San Antonio
The University of Texas Health Science Center at San Antonio
Not Provided
Principal Investigator: Eric M Mortensen, MD University of Texas Health Science Center/ South Texas Veterans Health Care System
The University of Texas Health Science Center at San Antonio
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP